Systems and methods for delivering an ocular implant to the suprachoroidal space within an eye

ABSTRACT

Delivery devices, systems and methods are provided for inserting an implant into an eye. The delivery or inserter devices or systems can be used to dispose or implant an ocular stent or implant, such as a shunt, in communication with a suprachoroidal space of the eye. The implant can drain fluid from an anterior chamber of the eye to a physiologic outflow path of the eye, such as, the suprachoroidal space or other portion of the uveoscleral outflow path. The delivery or inserter devices or systems can be used in conjunction with other ocular surgery, for example, but not limited to, cataract surgery through a preformed corneal incision, or independently with the inserter configured to make a corneal incision. The implant can be preloaded with or within the inserter to advantageously provide a sterile, easy-to-use package for use by an operator.

FIELD

This disclosure generally relates to intraocular pressure reduction andmore specifically to systems, devices and methods for delivering anintraocular implant to the suprachoroidal space within an eye to treatglaucoma, ocular hypertension and/or other ocular disorders.

BACKGROUND

A human eye is a specialized sensory organ capable of light receptionand is able to receive visual images. Aqueous humor is a transparentliquid that fills at least the region between the cornea, at the frontof the eye, and the lens. A trabecular meshwork, located in an anteriorchamber angle, which is formed between the iris and the cornea, normallyserves as a drainage channel for aqueous humor from the anterior chamberso as to maintain a balanced pressure within the anterior chamber of theeye.

Glaucoma is a group of eye diseases encompassing a broad spectrum ofclinical presentations, etiologies, and treatment modalities. Glaucomacauses pathological changes in the optic nerve, visible on the opticdisk, and it causes corresponding visual field loss, resulting inblindness if untreated. Lowering intraocular pressure is a majortreatment goal in glaucomas.

In glaucomas associated with an elevation in eye pressure (intraocularhypertension), a main source of resistance to outflow is typically inthe trabecular meshwork. The tissue of the trabecular meshwork normallyallows the aqueous humor (hereinafter also referred to as “aqueous”) toenter Schlemm's canal, which then empties into aqueous collectorchannels in the posterior wall of Schlemm's canal and then into aqueousveins, which form the episcleral venous system. Aqueous is continuouslysecreted by a ciliary body around the lens, so there is a constant flowof aqueous from the ciliary body to the anterior chamber of the eye.Pressure within the eye is determined by a balance between theproduction of aqueous and its exit through the trabecular meshwork(major route) and uveoscleral outflow (minor route) pathways. Theportion of the trabecular meshwork adjacent to Schlemm's canal (thejuxtacanilicular meshwork) can cause most of the resistance to aqueousoutflow.

Glaucoma is broadly classified into two categories: closed-angleglaucoma, also known as angle closure glaucoma, and open-angle glaucoma.Closed-angle glaucoma is caused by closure of the anterior chamber angleby contact between the iris and the inner surface of the trabecularmeshwork. Closure of this anatomical angle prevents normal drainage ofaqueous from the anterior chamber of the eye.

Open-angle glaucoma is any glaucoma in which the exit of aqueous throughthe trabecular meshwork is diminished while the angle of the anteriorchamber remains open. For most cases of open-angle glaucoma, the exactcause of diminished filtration is unknown. Primary open-angle glaucomais the most common of the glaucomas, and is often asymptomatic in theearly to moderately advanced stages of glaucoma. Patients may suffersubstantial, irreversible vision loss prior to diagnosis and treatment.

Most current therapies for glaucoma are directed toward decreasingintraocular pressure. Medical therapy includes topical ophthalmic dropsor oral medications that reduce the production of aqueous or increasethe outflow of aqueous. However, drug therapies for glaucoma aresometimes associated with significant side effects. The most frequentand perhaps most serious drawback to drug therapy, especially theelderly, is patient compliance. Patients often forget to take theirmedication at the appropriate times or else administer eye dropsimproperly, resulting in under- or overdosing. Patient compliance isparticularly problematic with therapeutic agents requiring dosingfrequencies of three times a day or more, such as pilocarpine. Becausethe effects of glaucoma are irreversible, when patients dose improperly,allowing ocular concentrations to drop below appropriate therapeuticlevels, further permanent damage to vision occurs.

SUMMARY

As such, a need exists for a more facile, convenient, less invasive, andless traumatic means of delivering an intraocular pressure controllingimplant into an eye while providing a cost-effective but safe surgicalprocedure. It is one advantage of certain embodiments of theinvention(s) disclosed herein to provide delivery devices, systems andmethods for inserting an implant into an eye. The delivery or inserterdevices or systems can be used to dispose or implant an ocular stent orimplant, such as a shunt, in communication with the suprachoroidalspace, uveoscleral outflow pathway (sometimes referred to as uvealscleral outflow pathway) and/or supraciliary space of the eye. Theimplant can drain fluid from an anterior chamber of the eye to aphysiologic outflow path of the eye, such as, the suprachoroidal space,uveoscleral outflow pathway, or supraciliary space. Alternatively, or inaddition, the implant can elute a drug or therapeutic agent. Thedelivery or inserter devices or systems can be used in conjunction withother ocular surgery, for example, but not limited to, cataract surgerythrough a preformed corneal incision, or independently with the inserterconfigured to make a corneal or limbal incision. The implant can bepreloaded with or within the inserter to advantageously provide anoperator-friendly package, such as a sterile package, for convenient useby a surgeon, doctor or operator. In some embodiments, the implant isnot preloaded within the delivery device or inserter and/or is notprovided within the same package as the delivery device or inserter.

While a majority of the aqueous leaves the eye through the trabecularmeshwork and Schlemm's canal, it is believed that at least about 10 toabout 20 percent of the aqueous in humans leaves through the uveoscleralpathway. The degree with which uveoscleral outflow contributes to thetotal outflow of the eye appears to be species dependent. As usedherein, the term “uveoscleral outflow pathway” is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and it is not to be limited to a special or customized meaning), andrefers without limitation to the space or passageway whereby aqueousexits the eye by passing through the ciliary muscle bundles located ator near an angle of the anterior chamber and into the tissue planesbetween the choroid and the sclera, which extend posteriorly to theoptic nerve. From these tissue planes, it is believed that the aqueoustravels through the surrounding scleral tissue and drains via thescleral and conjunctival vessels, or is absorbed by the uveal bloodvessels.

As used herein, the term “supraciliary space” is to be given itsordinary and customary meaning to a person of ordinary skill in the art(and it is not to be limited to a special or customized meaning), andrefers without limitation to the portion of the uveoscleral pathwaythrough the ciliary muscle and between the ciliary body and the sclera,and the term “suprachoroidal space” is to be given its ordinary andcustomary meaning to a person of ordinary skill in the art (and it isnot to be limited to a special or customized meaning), and referswithout limitation to the portion of the uveoscleral outflow pathwaybetween the choroid and sclera.

The term “implant” as used herein is a broad term, and is to be givenits ordinary and customary meaning to a person of ordinary skill in theart (and it is not to be limited to a special or customized meaning),and refers without limitation to drainage shunts, stents, sensors, drugdelivery implants, drugs, therapeutic agents, fluids, or any otherdevice or substance capable of being permanently or temporarily insertedwithin an eye and left within a body after removal of a deliveryinstrument.

As used herein, “implants” refers to ocular implants which can beimplanted into any number of locations in the eye. In some embodiments,the ocular implants are drainage implants designed to facilitate orprovide for the drainage of aqueous humor from the anterior chamber ofan eye into a physiologic outflow pathway in order to reduce intraocularpressure. In some embodiments, the implant can be configured to providea fluid flow path for draining aqueous humor from the anterior chamberto a uveoscleral outflow pathway. In some embodiments, the aqueous humoris diverted to the supraciliary space and/or the suprachoroidal space ofthe uveoscleral outflow pathway.

If desired, more than one implant of the same or different type may beimplanted. For example, the implants disclosed herein may be used incombination with trabecular bypass shunts, such as those disclosed inU.S. Patent Publication 2004/0050392, filed Aug. 28, 2002, and thosedescribed in U.S. Patent Publication 2005/0271704, filed Mar. 18, 2005,the entire contents of each of which are incorporated herein byreference. Additionally, implantation may be performed in combinationwith other surgical procedures, such as cataract surgery. All or aportion of the implant may be coated, e.g. with heparin, preferably inthe flow path, to reduce blood thrombosis or tissue restenosis.

In some embodiments, at least some slight and/or predeterminedflexibility is provided to an obturator, or trocar, of an implantdelivery system for ocular tissue penetration and to conform with aneye's structure and anatomy at or along the pathway to an implantationsite. In some embodiments, at least some slight and/or predeterminedflexibility is provided to an implant or stent to conform with the eye'sstructure and anatomy at or along the pathway to an implantation site.The terms “obturator” and “trocar” are used interchangeably herein, andin addition to their ordinary meanings, may refer to an elongateinstrument with a generally rounded or non-sharp distal tip.

In accordance with several embodiments, an ocular implant deliverysystem includes a delivery device (e.g., an applicator or inserter) andan ocular implant. The implant may be preloaded on or within thedelivery device and provided as a kit within a package for convenientuse by an operator. The delivery device may include a generallyelongated outer housing that is ergonomically contoured. The deliverydevice may also include an elongated insertion sleeve partially disposedin the outer housing and having a non-linear exposed distal portionextending out of a distal end of the housing. The non-linear exposeddistal portion of the insertion sleeve may have a curvature adapted toconform to an anatomical curvature of the eye, such as the cornea and/orsclera. The delivery device may include an obturator, or trocar, passingthrough a lumen of the insertion sleeve and having a non-linear distalportion extending beyond the non-linear distal portion of the insertionsleeve. In one embodiment, the obturator has a rounded, blunt ornon-faceted distal end. In use, the non-linear distal portion of theobturator is adapted to provide access to a suprachoroidal space througha ciliary muscle attachment. In one embodiment, the access is providedwithout dissecting a ciliary body portion at the anterior chamber anglefrom the sclera but instead is provided by insertion of the obturatorthrough a fibrous band of the ciliary muscle. In some embodiments, thenon-linear distal portion of the obturator is flexible and has acurvature adapted to maintain pressure against the sclera duringinsertion into the suprachoroidal space. The delivery device may alsoinclude a trigger operatively coupled to the obturator such thatmovement of the trigger towards a proximal end of the housing retractsthe obturator within the insertion sleeve, thereby deploying the implantoff of the obturator.

The implant is adapted to be disposed on the non-linear portion of theobturator and positioned distally of the non-linear distal portion ofthe insertion sleeve prior to insertion of the delivery device into aneye. For example, the implant may be loaded on the obturator byinserting a distal end of the obturator within a lumen of the implantand advancing the implant over the obturator or advancing the obturatortoward a distal end of the implant. In some embodiments, in use, adistal end of the insertion sleeve is adapted to react against aproximal end of the implant as the obturator is being retracted todeliver the implant. The insertion sleeve may be sized to extend througha corneal incision and into an anterior chamber of the eye. In someembodiments, the implant has a curvature which substantially matches thecurvature of the non-linear portion of the obturator. In someembodiments, the curvature of the non-linear distal portion of theobturator and/or the implant is larger than a diameter of the eye.

In use, the trigger may be manually controlled and held in a forwardposition, and retracted in a backward motion to cause delivery of theimplant once a distal end of the implant has been advanced to a desiredlocation within the suprachoroidal space, wherein the backward motion ofthe obturator is adapted to prevent against over-insertion of theimplant within the suprachoroidal space. In some embodiments, a distaltip of the obturator is rounded so as not to cause scraping of thesclera while still being adapted to provide access to the suprachoroidalspace through the ciliary muscle attachment.

In some embodiments, the implant is an elongate tube having an outerdiameter of the implant is between 300 and 400 microns. In someembodiments, a distal portion of the implant includes a plurality ofcircumferential retention members. A distal tip of the implant may betapered. A proximal end of the implant may include a flange. In someembodiments, the delivery device includes reuse prevention structuresconfigured to limit use to a single use. For example, the reuseprevention structures ma include a pair of glue blocks mounted on eachside of a trigger of the obturator adapted to melt upon sterilization tolock the trigger against further use.

In accordance with several embodiments, an ocular implant deliverysystem includes a delivery device, applicator or inserter having agenerally elongated outer housing that is ergonomically contoured and anelongated insertion needle partially disposed in the outer housing andhaving a non-linear exposed distal portion. The delivery device mayfurther include an implant pusher tube extending through a lumen of theelongated insertion needle and having a non-linear distal portion. Inone embodiment, the delivery device includes an obturator passingthrough a lumen of the pusher tube and having a non-linear distalportion. In use, the non-linear distal portion of the obturator may beadapted to provide access to a suprachoroidal space through a ciliarymuscle attachment. The non-linear distal portion of the obturator may beflexible and have a curvature adapted to maintain pressure against thesclera during insertion into the suprachoroidal space. The deliverydevice may also include a pusher tube trigger operatively coupled to thepusher tube such that movement of the pusher tube trigger towards aproximal end of the housing retracts the obturator toward the housing.In use, a distal end of the pusher tube may be adapted to react againsta proximal end of an implant loaded on to the obturator as the obturatoris being retracted within the housing to deliver the implant.

In one embodiment, the insertion needle is a corneal penetration needle(e.g., a 25±5 gauge needle) adapted to create a self-sealing cornealincision (e.g., at or near the corneal limbus). The non-linear portionsof the insertion needle, pusher tube and/or obturator may have asubstantially matching curvature. The system may also include an implantpreloaded onto the obturator and provided together with the deliverydevice in a kit or packaging. The implant may have a curvature thatsubstantially conforms to or matches, the curvatures of the insertionneedle, pusher tube and obturator.

In some embodiments, the pusher tube trigger is operatively coupled to atrigger of the obturator. The obturator may be advanceable andretractable by actuation of the trigger of the obturator. In someembodiments, when the pusher tube is fully advanced the pusher tube islocked to prevent further motion. The delivery device may include reuseprevention structures designed and/or adapted to limit use of thedelivery device to a single use. For example, the reuse preventionstructures may include a pair of glue blocks mounted on each side of thepusher tube trigger adapted to melt upon sterilization to lock thepusher tube trigger against further use.

In accordance with several embodiments, an ocular implant deliverydevice includes a generally elongated outer housing that isergonomically contoured and an elongated insertion sleeve partiallydisposed in the outer housing and having a non-linear exposed distalportion. The ocular implant delivery device may also include a tubularsupport member surrounding a portion of the elongated insertion sleeve.The tubular support member may have a proximal end within the outerhousing and a distal end extending outside of the outer housing. Thetubular support member may be configured to facilitate coupling of theelongated insertion sleeve to the outer housing. The tubular supportmember may surround a portion of the elongated insertion sleeve. Thedelivery device may also include an obturator passing through a lumen ofthe elongated insertion sleeve and having a non-linear distal portionextending beyond the non-linear exposed distal portion of the elongatedinsertion sleeve and a trigger operatively coupled to the obturator suchthat actuation of the trigger retracts the obturator into the insertionsleeve, thereby causing a proximal end of an implant disposed on thenon-linear portion of the obturator to react against a distal end of theinsertion sleeve so as to facilitate deployment of the implant from theobturator. In some embodiments, the non-linear distal portion of theobturator carrying the implant is configured to be advanced into asuprachoroidal space of an eye and the non-linear distal portion of theobturator has a curvature configured to be larger than a diameter of theeye.

For purposes of summarizing embodiments of the invention(s), certainaspects, advantages and novel features of the invention have beendescribed herein above. Of course, it is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment of the invention. Thus, the invention may beembodied or carried out in a manner that achieves or optimizes oneadvantage or group of advantages as taught or suggested herein withoutnecessarily achieving other advantages as may be taught or suggestedherein.

All of these embodiments are intended to be within the scope of theinvention herein disclosed. These and other embodiments of the inventionwill become readily apparent to those skilled in the art from thefollowing detailed description of the preferred embodiments havingreference to the attached figures, the invention not being limited toany particular preferred embodiment(s) disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Having thus summarized the general nature of some of the embodiments ofthe invention(s) and some of their features and advantages, certainpreferred embodiments and modifications thereof will become apparent tothose skilled in the art from the detailed description herein havingreference to the figures that follow, which are intended to illustrateand not to limit the disclosure.

FIG. 1 is a simplified schematic sectional view of a portion of an eyeillustrating certain ocular anatomical features thereof and therein.

FIG. 2 is a simplified perspective view of an implant delivery devicepreloaded with an ocular implant (which is shown in detail in FIG. 2A),illustrating features and advantages in accordance with certainembodiments.

FIG. 3 is a simplified exploded perspective view of the implant deliverydevice of FIG. 2 illustrating features and advantages in accordance withcertain embodiments.

FIG. 4 is a simplified partially cut-off side view of the implantdelivery device of FIG. 2 illustrating features and advantages inaccordance with certain embodiments.

FIG. 5 is a simplified side view of an ocular implant illustratingfeatures and advantages in accordance with certain embodiments.

FIG. 6 is a simplified bottom or lower view of the ocular implant ofFIG. 5 illustrating features and advantages in accordance with certainembodiments.

FIG. 7 is a simplified top or upper view of the ocular implant of FIG. 5illustrating features and advantages in accordance with certainembodiments.

FIG. 8 is a simplified sectional view along line 8-8 of the ocularimplant of FIG. 7 illustrating features and advantages in accordancewith certain embodiments.

FIG. 9 is a simplified side view of an insertion sleeve of the implantdelivery device of FIG. 2 illustrating features and advantages inaccordance with certain embodiments.

FIG. 10 is a simplified perspective view of an insertion sleeve assemblyof the implant delivery device of FIG. 2 , including the insertionsleeve of FIG. 9 , illustrating features and advantages in accordancewith certain embodiments.

FIG. 11 is a simplified side view of the insertion sleeve assembly ofFIG. 10 illustrating features and advantages in accordance with certainembodiments.

FIG. 12 is a simplified perspective of a trocar assembly of the implantdelivery device of FIG. 2 illustrating features and advantages inaccordance with certain embodiments.

FIG. 13 is a simplified side view of the trocar assembly of FIG. 12illustrating features and advantages in accordance with certainembodiments.

FIG. 14 is a simplified distal end view of the trocar assembly of FIG.12 illustrating features and advantages in accordance with certainembodiments.

FIG. 15 is a simplified proximal end view of the trocar assembly of FIG.12 illustrating features and advantages in accordance with certainembodiments.

FIG. 16 is a simplified perspective view of a trocar trigger of theimplant delivery device of FIG. 2 illustrating features and advantagesin accordance with certain embodiments.

FIG. 17 is a simplified perspective view of a safety clip of the implantdelivery device of FIG. 2 illustrating features and advantages inaccordance with certain embodiments.

FIGS. 18 to 22 are simplified schematic views illustrating a surgicalprocedure or method of implanting an ocular implant in thesuprachoroidal space of an eye using the implant delivery device of FIG.2 , having features and advantages in accordance with certainembodiments, wherein: FIG. 18 illustrates insertion of the implant andthe delivery device into an anterior chamber of the eye; FIG. 19illustrates positioning of the implant at an implantation site; FIG. 20illustrates advancement and implantation of the implant in asuprachoroidal space formed between the choroid and the sclera; FIG. 21illustrates retraction of a trocar of the delivery device from thesuprachoroidal space; and FIG. 22 illustrates the removal of thedelivery device from the anterior chamber of the eye with the implantremaining within the eye.

FIG. 23 is a simplified perspective view of an implant delivery device,preloaded with an ocular implant, illustrating features and advantagesin accordance with certain embodiments.

FIG. 24 is a simplified exploded perspective view of the implantdelivery device, including the implant, of FIG. 23 illustrating featuresand advantages in accordance with certain embodiments.

FIG. 25 is a simplified side view of a penetration needle of the implantdelivery device of FIG. 23 illustrating features and advantages inaccordance with certain embodiments.

FIG. 26 is a simplified bottom or lower view of the penetration needleof FIG. 25 illustrating features and advantages in accordance withcertain embodiments.

FIG. 27 is a simplified perspective view of a penetration needleassembly of the implant delivery device of FIG. 23 , including thepenetration needle of FIG. 25 , illustrating features and advantages inaccordance with certain embodiments.

FIG. 28 is a simplified side view of the penetration needle assembly ofFIG. 27 illustrating features and advantages in accordance with certainembodiments.

FIG. 29 is a simplified top or upper view of the penetration needleassembly of FIG. 27 illustrating features and advantages in accordancewith certain embodiments.

FIG. 30 is a simplified sectional view along line 30-30 of FIG. 29illustrating features and advantages in accordance with certainembodiments.

FIG. 31 is a simplified perspective view of a trocar assembly of theimplant delivery device of FIG. 23 illustrating features and advantagesin accordance with certain embodiments.

FIG. 32 is a simplified side view of the trocar assembly of FIG. 31illustrating features and advantages in accordance with certainembodiments.

FIG. 33 is a simplified perspective view of a trocar trigger of theimplant delivery device of FIG. 23 illustrating features and advantagesin accordance with certain embodiments.

FIG. 34 is a simplified perspective view of a pusher tube assembly ofthe implant delivery device of FIG. 23 illustrating features andadvantages in accordance with certain embodiments.

FIG. 35 is a simplified side view of the pusher tube assembly of FIG. 34illustrating features and advantages in accordance with certainembodiments.

FIG. 36 is a simplified perspective view of a pusher tube trigger of theimplant delivery device of FIG. 23 illustrating features and advantagesin accordance with certain embodiments.

FIG. 37 is a simplified perspective detail view from FIG. 24 of theengagement between a collar of the trocar assembly and the trocartrigger and between a collar of the pusher tube assembly and the pushertube trigger illustrating features and advantages in accordance withcertain embodiments.

FIGS. 38A and 38B illustrate an implant loaded on the obturator, ortrocar, of the delivery device of FIG. 23 and a distal end of thedelivery device of FIG. 23 , respectively, in accordance with certainembodiments.

FIGS. 39 to 44 are simplified schematic views illustrating a surgicalprocedure or method of implanting an ocular implant in thesuprachoroidal space of an eye using the implant delivery device of FIG.23 , having features and advantages in accordance with certainembodiments, wherein: FIG. 39 illustrates insertion of the implant andthe delivery device into an anterior chamber of the eye through anincision made by an insertion needle of the delivery device; FIG. 40illustrates deployment of a trocar and a pusher tube of the delivery orinserter system or device such that the implant is exposed within theanterior chamber; FIG. 41 illustrates positioning of the implant at animplantation site; FIG. 42 illustrates advancement and implantation ofthe implant in the suprachoroidal space; FIG. 43 illustrates retractionof a trocar of the delivery device from the suprachoroidal space; andFIG. 44 illustrates the removal of the delivery device from the anteriorchamber of the eye with the implant remaining within the eye.

DETAILED DESCRIPTION

The preferred embodiments of the invention described herein relategenerally to intraocular pressure reduction and, in particular, tosystems, devices and methods for delivering an intraocular implant tothe suprachoroidal space, supraciliary space or other anatomical spacewithin a uveoscleral outflow pathway of an eye to treat glaucoma, ocularhypertension and/or other ocular disorders.

While the description sets forth various embodiment specific details, itwill be appreciated that the description is illustrative only and shouldnot be construed in any way as limiting the invention. Furthermore,various applications of the invention, and modifications thereto, whichmay occur to those who are skilled in the art, are also encompassed bythe general concepts described herein.

FIG. 1 shows relative anatomical features of an eye 10. The featuresinclude an anterior chamber 32 and a sclera 38, which is a thickcollagenous tissue that covers the entire eye 10 except a portion thatis covered by a cornea 36. The cornea 36 is a thin transparent tissuethat focuses and transmits light into the eye and through a pupil 42,which is a generally circular hole in the center of an iris 44 (coloredportion of the eye), to a lens 48. The cornea 36 merges into the sclera38 at a juncture referred to as a limbus 45. Ciliary bodies 46 arevascular tissue that extend along the interior of the sclera 38 from theouter edges of the iris in the limbal region to a choroid 40.

The anterior chamber 32 of the eye 10, which is bound anteriorly by thecornea 36 and posteriorly by the iris 44 and the lens 48, is filled withaqueous humor or aqueous fluid (which may be simply referred to hereinas aqueous). Aqueous is produced primarily by the ciliary bodies 46 andflows into the posterior chamber, bounded posteriorly by the lens 48 andanteriorly by the iris 44. The aqueous humor then flows anteriorlythrough the pupil 42 and into the anterior chamber 32 until it reachesan anterior chamber angle 50, formed generally between the iris 44 andthe cornea 36.

In a normal eye, at least some of the aqueous humor drains from theanterior chamber 32 through a trabecular meshwork into Schlemm's canaland thereafter through a plurality of collector ducts and aqueous veins,which merge with blood-carrying veins, and into systemic venouscirculation. Intraocular pressure is maintained by an intricate balancebetween secretion and outflow of aqueous humor in the manner describedabove. Glaucoma is, in most cases, characterized by an excessive buildupof aqueous humor in the anterior chamber 32, which leads to an increasein intraocular pressure. Fluids are relatively incompressible, and thus,intraocular pressure is distributed relatively uniformly throughout theeye 10.

The choroid 40 is a vascular layer of the eye 10 located between thesclera 38 and a retina (not identified in FIG. 1 ). An optic nerve (notshown) transmits visual information to the brain and is the anatomicstructure that is progressively destroyed by glaucoma, ocularhypertension, and/or other ocular or ophthalmic disorders.

Another existing aqueous drainage route is provided through asuprachoroidal space 34, which is a space or region generally definedbetween the sclera 38 and the choroid 40. The suprachoroidal space 34 isexposed to the anterior chamber 32 through the anterior chamber angle50. The tissue connection between the anterior chamber 32 andsuprachoroidal space 34 is generally via a fibrous attachment zone 60generally disposed between a scleral spur 62 and iris processes 64and/or ciliary muscle 66, which is a part of the choroid 40.

Certain embodiments of suprachoroidal implants, delivery devices,associated components and suprachoroidal implantation methods andprocedures, and the like, among others, are disclosed in U.S. PatentApplication Publication No. 2008/0228127, published Sep. 18, 2008, theentire content of which is incorporated by reference herein.

Delivery Device for Advancing Implant Through Pre-Formed CornealIncision

FIGS. 2-4 show different views of an implant delivery device orapplicator 110, preloaded with an ocular implant 120, in accordance withsome embodiments. The delivery device 110 is configured to implant atleast a portion of the implant 120 in the suprachoroidal space 34 of theeye 10. In some embodiments, the delivery method is performed via an abinterno insertion procedure. In some embodiments, the implant deliverymethod is performed in combination with other ocular surgery, such ascataract surgery, and the implant is delivered through a preformedincision in the cornea or at the corneal limbus, which may be formed inconjunction with the other ocular surgery. The incision may be aself-sealing incision to facilitate quick recovery without requiringsutures. In some embodiments, the ocular implant 120 is not preloadedwithin delivery device 110 (e.g., not preloaded in packaging at time ofshipping).

The implant delivery device 110 can be provided in a sterile packagingfor single-use operation. For example, a double polythene bag may beused for sterility purposes, in combination with a blister packaging tofacilitate use by the operator while still maintaining safe usage.

The delivery device 110 is generally elongate in structure, andgenerally comprises an outer housing and handpiece 122, an implantretainer 124 (see FIG. 2A), an insertion sleeve, tube or needle assembly126, a trocar assembly 128, a trocar trigger 130, a trigger safetydevice 132 and a pair of reuse prevention structures 134 a and 134 b.

The outer housing 122 encloses various componentry of the deliverydevice 110 and can comprise two housing portions such as a left housingportion 136 a and a right housing portion 136 b, which can be attachedduring fabrication of the delivery device 110.

Selected portions of the outer housing and handpiece 122 have ergonomicfeatures such as the hand grip area 138 a, which has a ribbed texture orthe like to facilitate manual handling by a surgeon, medical operator orpractitioner (a similar hand grip area may be provided on the righthousing portion 136 b). Various internal structures of the outer housing122 engage the other components of the delivery device 110, as discussedfurther below.

The outer housing 122 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the outer housing 122 comprises a thermoplastic materialsuch as medical grade polycarbonate that is gamma stable.

The outer housing 122 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the outer housing 122 has a length of about 5.60 inches,though other lengths may also be efficaciously utilized, for example,based on the size of the user's hand (e.g., between about 4 inches andabout 8 inches or any length in between).

The implant retainer 124 (see FIG. 2A) is a generally disc shapedstructure that is removably mounted on a distal tip of the trocarassembly 128 just distally of the implant 120. The implant retainer 124is removed before the delivery device 110 is used. The implant retainer124 may prevent undesirable movement of the implant 120 and prevent theimplant 120 from sliding off the distal tip of the trocar assembly 128during packaging, shipping and travel of the implant delivery device110. The implant retainer 124 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the implant retainer 124 comprises molded silicone.

The insertion sleeve assembly 126 generally comprises an insertionsleeve 140 and a support member 142 fixedly attached thereto and to theouter housing 122. The insertion sleeve 140 may comprise a sleeve, tubeor needle. The support member 142 may comprise a sleeve. Distal portionsof the insertion sleeve 140 and support member 142 are exposed andextend beyond the distal tip of the delivery device 110 while proximalportions of the insertion sleeve 140 and support member 142 arecontained within the outer housing 122. The insertion sleeve assembly126 is discussed in further detail later herein.

The trocar assembly 128 generally comprises an obturator, or trocar, 144and a trocar support member 146 attached thereto. The trocar supportmember 146 is mechanically coupled, connected or attached to theactuatable trocar trigger 130. In one embodiment, the trocar supportmember 146 is a clip, as illustrated in FIGS. 2-4 . A substantialportion of the trocar 144 can extend through the insertion sleeve 140with a distal portion extending beyond the insertion sleeve 140 on whichthe implant 120 is located. A proximal portion of the trocar 144 and thetrocar support member 146 are contained within the outer housing 122.The trocar assembly 128 is discussed in further detail later herein.

The trocar trigger 130 generally comprises an upper finger or thumbactuatable portion 148 and a lower main body portion 150. The actuatabletrigger portion 148 generally extends above the housing 122 while themain body portion 150 is generally contained within the housing 122.Before use, the trocar trigger 130 is in a forward position and, when inuse, it is utilized to retract the trocar 144. The trigger main bodyportion 150 is mechanically coupled, connected or attached to the trocarassembly 128. The trocar trigger 130 is discussed in further detaillater herein.

The trigger safety device 132 is removable and is positioned generallyrearwardly with respect to the trocar trigger 130 and is mechanicallycoupled or engaged with the trocar trigger 130. The trigger safetydevice 132 prevents undesirable motion of the trocar trigger 130 duringpackaging, shipping and travel of the implant delivery device 110, asalso discussed further below. In one embodiment, the trigger safetydevice 132 is a clip.

The reuse prevention structures 134 a and 134 b are mounted on each sideof the trocar trigger 130 and within the outer housing 122. The reuseprevention structures 134 a and 134 b may advantageously provide asafety function to disallow reuse of the delivery device 110 so as toprevent any cross-contamination between unauthorized reuse of the singleuse device 110. As discussed further below, the reuse preventionstructures 134 a and 134 b, in one embodiment, are glue blocks orpreform structures that are adapted to melt, dissolve or otherwiseshrink or disappear when any unapproved re-sterilization of the deliverydevice 110 is attempted and lock or jam the trocar trigger 130 so thatits movement is thwarted. In some embodiments, a hot melt adhesive isused to freeze the trigger mechanism and prevent use after autoclave.

FIGS. 5-8 show different views of the ocular implant, stent or shunt 120in accordance with some embodiments. The implant 120 generally comprisesan elongate implant body 151 and a proximal implant sleeve 152. Theimplant 120 and/or the implant body 151 comprises a lumen, channel,pathway or passage 154 extending therethrough for drainage of fluid(e.g., aqueous) from the anterior chamber 32 to the suprachoroidal space34 and a plurality of generally circumferential retention features orstructures, ribs, rings or anchors 156 to facilitate implantation andretention and/or stability in the suprachoroidal space 34. In theillustrated embodiment, the implant 120 comprises four retentionfeatures; however, other numbers of retention features may be used(e.g., two, three, five, six, seven, eight or more).

The implant 120 and/or the implant body 151 further comprises respectivedistal and proximal ribs, flanges or stops 158 and 160 which may holdthe sleeve 152 in place. Moreover, the proximal structure 160 isdimensioned so that the implant cannot move rearwardly with respect tothe distal end of the insertion sleeve 140. Thus, the insertion sleeve140 can act as a backing tube to react against a proximal end of theimplant 120 during removal of the implant 120 from the delivery device110.

Advantageously, the implant 120 and/or the implant body 151 has apredetermined curvature and/or flexibility that substantially matchesthe curvature of the sclera and/or facilitates proper insertion in thesuprachoroidal space 34. In some embodiments, the curvature of theimplant 120 is configured to keep pressure on the sclera duringimplantation and prevent “understeer” and/or choroid penetration. Insome embodiments, the curvature of implant is greater than a diameter ofthe eye (e.g., greater than 1 inch). The lumen 154, in accordance withcertain embodiments, allows for drainage or flow of fluid (e.g.,aqueous) from the anterior chamber 32 to the suprachoroidal space 34.The length of the implant 120 can range from about 1 mm to about 8 mm(e.g., 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm).

The implant 120 can efficaciously be fabricated from various suitablematerials, as required or desired. In one non-limiting embodiment, theimplant body 151 comprises a plastic, such as polyethersulfone (PES),and the sleeve 152 comprises a metal or alloy, such as titanium or atitanium alloy. In some embodiments, the sleeve 152 provides a visualaid in determining the proper depth of stent placement duringimplantation (e.g., one or more radiopaque markers).

The implant 120, in some embodiments, can also comprise a therapeuticagent or drug. For example, at least a portion of the implant 120 iscoated with a therapeutic agent or drug. In one embodiment, at least theimplant lumen 154 is coated with a therapeutic agent or drug, such as,but not limited to, heparin or the like.

The implant 120 can be efficaciously dimensioned in various suitablemanners, as required or desired. In one non-limiting embodiment, theradius of curvature R₈ is about 1 inch, the diameter D₈ is about atleast 0.0063 inches, and the diameter D₅ is about at least 340 microns.In some embodiments, the curvature is larger than the diameter of theeye (e.g., larger than 1 inch) to maintain pressure on the sclera duringimplantation. The implant 120 can be symmetrically designed such that itmay be used in either the left or right eye. Other implants can bedelivered by the delivery devices 110, 210 in addition to the implant120.

FIGS. 9-11 show different views of the insertion sleeve assembly 126 andinsertion sleeve 140 in accordance with some embodiments. The insertionsleeve 140 is a generally elongated tubular structure with a lumen 162extending therethrough and a distal curved or non-linear portion 164 todesirably facilitate ab interno suprachoroidal implantation.

The insertion sleeve support 142 is an elongated member through which aportion of the insertion sleeve 140 extends and is fixedly attachedthereto. The insertion sleeve support 142 includes a collar 166 whichmates with a corresponding portion of the outer housing 122 to fixedlyattach these structures.

The insertion sleeve 140 receives a portion of the trocar 144 whichpasses through the sleeve lumen 162. The sleeve distal curved ornon-linear portion 164 advantageously provides proper curvature andalignment of the trocar 144 and/or the implant 120 for suprachoroidalimplantation.

The insertion sleeve assembly 126 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the insertion sleeve 140 and sleeve support 142 comprise aliquid crystal polymer or thermoplastic such as polycarbonate which aremolded to form the assembly. In another non-limiting embodiment, theinsertion sleeve 140 and sleeve support 142 comprise stainless steel andare welded (spot or continuous) to form the assembly. The insertionsleeve 140 can efficaciously comprise 26±5 gauge hypodermic tubing, asrequired or desired, including 21, 22, 23, 24, 25, 26, 27, 28, 29, 30and 31 gauge.

The insertion sleeve assembly 126 can be efficaciously dimensioned invarious suitable manners, as required or desired. In one non-limitingembodiment, the length L₉₁ is about 1.8 inches, the length L₉₂ is about0.06 inches, the diameter D₉₁ is about 0.018 inches, the diameter D₉₂ isabout 0.001 inches, the radius of curvature R₉ is about 0.11 inches, andthe angle θ₉ is about 28° (degrees).

FIGS. 12-15 show different views of the trocar assembly 128, inaccordance with some embodiments. The obturator, or trocar, 144 is agenerally elongated structure with a curved or non-linear distal portion168 having a distal-most end 170 that is configured to optimallypenetrate ocular tissue so as to access the suprachoroidal space 34. Inone embodiment, the distal-most end is rounded to glide smoothly downthe sclera while still being adapted to dissect and separate the ciliarymuscle attachment in order to enter the suprachoroidal space 34atraumatically. In one embodiment, the distal-most end is adapted topuncture through a fibrous band at the anterior chamber angle to enterthe suprachoroidal space 34.

The obturator, or trocar, 144 extends through the trocar support member146, which is configured to engage the trocar trigger 130, and beretractable on actuation of the trocar trigger 130. The curved distalportion 168 may have a predetermined curvature to allow a proper angleof attack to penetrate ocular tissue to provide access for implantationof the implant 120 in the suprachoroidal space 34. The trocar may haveslight flexibility to facilitate conformance to the eye anatomy duringinsertion. In one embodiment, the predetermined curvature is adapted tokeep pressure on the sclera during implantation and prevent or inhibit“understeer” or choroid penetration.

In some embodiments, the trocar support member 146 is configured tomechanically engage, couple, connect or fixedly attach to a recessedportion of the trocar trigger 130. Thus, actuation or retraction of thetrocar trigger 130 may result in movement and retraction of theobturator, or trocar 144.

The trocar assembly 128 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar 144 comprises a metal or metal alloy such asspring tempered 304 stainless steel with a predetermined flexibility andresilience, and the trocar support member 146 comprises a metal or metalalloy such as 301 stainless steel with a predetermined hardness. Thetrocar 144 and trocar support member 146 can be welded together, suchas, denoted by weld spots 172, or otherwise attached in other suitablemanners, for example molding and the like, as needed or desired.

The trocar assembly 128 can be efficaciously dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₁₃ of the trocar distal curvedportion 168 is about 1 inch (which generally conforms to the implant'sradius of curvature and may prevent implant creep), the diameter D₁₃ isabout 0.006 inches (which provides a low tolerance fit within theimplant's lumen), the length L₁₃ is about 0.17 inches, the overallunbent length of the trocar 144 is about 2.3 inches, and the radius ofcurvature of the trocar distal end tip 170 is in the range from about0.001 to about 0.003 inches. In various embodiments, the radius ofcurvature R₁₃ of the trocar distal curved portion 168 can range from 0.4inches to about 2.2 inches. In one embodiment, the curvature of thedistal curved portion 168 is configured to be larger than the diameterof the eye (e.g., larger than 1 inch) in order to maintain pressureagainst the sclera during the implantation procedure.

FIG. 16 shows a different view of the trocar trigger 130, in accordancewith some embodiments. The ergonomic upper finger or thumb touch portion148 has a ribbed texture configuration to facilitate its actuation bythe operator. The lower main body portion 150 has several features thatallow for the operation of the trocar trigger 130.

The trigger main body portion 150 comprises a slot, cavity, opening orrecessed portion 171 which mates with and attaches to a portion of thetrocar support member 146 (e.g., clip) thereby effectively coupling andconnecting the trocar trigger 130 and the trocar 144. The trigger mainbody portion 150 may also comprise multiple pins 174 disposed generallysymmetrically on either side, which slidably engage the internalstructure of the outer housing 122, such as the left and right slotstherein (one of which slots is depicted by reference numeral 178 b inFIGS. 3 and 4 ).

The trigger main body portion 150 further comprises slots 176 on eachside that respectively receive the reuse prevention structures 134 a and134 b (e.g., glue blocks) that are mounted therein. As noted above, anddiscussed further herein, the glue blocks can be configured to melt,dissolve, or otherwise shrink or disappear and lock the trocar trigger130 to prevent unapproved use for the safety of the patient. Other reuseprevention mechanisms may also be used. In some embodiments, a hot meltadhesive is used to freeze the trigger mechanism and prevent use afterautoclave.

The trocar trigger 130 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar trigger 130 comprises a plastic or thermoplastic,such as polyethylene.

FIG. 17 shows a different view of the removable trigger safety device132, in accordance with some embodiments. An upper portion 178 isexposed above the outer housing 122 and a lower portion 180 is containedwithin the outer housing 122. As shown, the trigger safety device 132can comprise a clip mechanism.

As noted earlier, the trigger safety device 132 is configured to preventor inhibit undesirable motion of the trocar trigger 130 duringpackaging, shipping and travel of the implant delivery device 110. Thelower portion 180 is engaged with the trocar trigger 130 prior to use ofthe delivery device 110 and, by manipulation of the upper portion 178,the trigger safety device 132 is removed from the delivery device 110prior to the surgical procedure.

The trigger safety device 132 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the trigger safety device 132 comprises a thermoplastic suchas a polycarbonate, for example, Makrolon® 2458.

The delivery device 110 generally comprises, but is not limited to,materials composed of stainless steel, molded plastic and silicone,among others and equivalents thereof.

Methods of Implant Delivery Through Pre-Formed Corneal Incision

FIGS. 18-22 show some steps or acts of a surgical procedure or method ofimplanting the ocular implant 120 in the suprachoroidal space 34 of theeye 10 using the implant delivery device 110 in accordance with someembodiments. Given the details in the figures, the surgical methodshould be self-explanatory; however some textual description is providedbelow.

In some embodiments, a cohesive viscoelastic is added to the anteriorchamber, as needed, to maintain intraocular pressure for use of agonioprism (surgeons may select a cohesive viscoelastic of theirpreference, including but not limited to, Healon, Amvisc or Provisc)through the incision created for implant or stent delivery or othersurgery (e.g., cataract surgery).

If a gonioprism is used for visualization, the gonioprism is placed onthe cornea. A surgical microscope and patient may be positioned toprovide clear visualization of the trabecular meshwork on the nasal sideof the eye through the gonioprism. The patient's head may be tilted asfar as practical away from the surgeon, and the microscope may be tiltedtoward the surgeon to ensure a proper viewing angle.

In some embodiments, the anterior chamber angle is inspected using thegonioprism or other visualization member to ensure good visualization atthe nasal implant location.

The implant delivery device 110 is removed from the blister tray and theimplant retainer 124 is removed from the implant and trocar tip (e.g.,using fine forceps) without disrupting the implant position and takingcare that the implant 120 does not slide off the trocar 144.

The trigger safety device 132 may then be removed, taking care onceagain that the implant 120 does not slide off the trocar 144, and thatthe trocar trigger 130 is maintained in the forward position by theoperator, and does not slide rearward.

If required, the anterior chamber can be deepened by injectingadditional cohesive viscoelastic into the anterior chamber to aid inchamber maintenance. The inserter tip can be coated with a small drop ofviscoelastic, as required.

In accordance with some embodiments, the implantation procedure isperformed in conjunction with another ophthalmic procedure, such ascataract surgery, and as illustrated in FIG. 18 , the deliveryinstrument 110 with the implant 120 preloaded thereon at a distalportion thereof is introduced or inserted into the anterior chamber 32through a preexisting or preformed corneal or limbal incision 70. Theinsertion sleeve 140 extends through the incision 70 and into theanterior chamber 32. The trocar trigger 130 is maintained in the forwardposition by the operator. The delivery device 110 may be advanced to thepapillary margin before replacing the gonioprism onto the eye. In someembodiments, care is taken to avoid contact with the lens 48, cornea 36and iris 44. Preloading the implant 120 on the delivery instrument 110may reduce loading errors and contribute to ease of use.

As illustrated in FIG. 19 , the implant 120 may be advanced across theanterior chamber 32 to the anterior chamber angle 50 towards the scleralspur 62, until the trocar distal end 170 is adjacent the fibrousattachment zone 60. The trocar trigger 130 is maintained in the forwardposition by the operator. In accordance with some embodiments, the angleof attack θ₁₉ is about 15° (degrees), though 10, 11, 12, 13, 14, 15, 16,17, 18, 19 and 20° (degrees) or other attack angles may efficaciously beutilized, as needed or desired. In some embodiments, the delivery device110 has a built-in configuration or design for a generally downwardangle of about 15° (±5°-10°) (degrees) at the site of implantation ortowards this site.

Next, as illustrated in FIG. 20 , the trocar distal tip or end 170penetrates through the tissue of and/or adjacent the fibrous attachmentzone 60 and the implant 120 is advanced until its implantation positionhas been reached in the suprachoroidal space 34 with a predeterminedportion of the implant sleeve 152 extending into the anterior chamber32. The trocar trigger 130 is maintained in the forward position by theoperator. In some embodiments, the trocar distal tip or end 170 isadapted to dissect and separate the ciliary muscle attachment in orderto enter the suprachoroidal space atraumatically. In some embodiments, agenerally narrow passage may be created into the suprachoroidal space bygently separating the iris processes away from the scleral spur with thetip 170 of the insertion trocar until the anterior and posteriorportions of the scleral spur are substantially fully visible on alimited area—e.g., create an approximately 0.5 mm to a maximum of about1 mm width opening. The implant or stent 120 may then be advanced untilthe anterior surface of the implant or stent is substantially tangent tothe posterior margin of the scleral spur. With finger or thumb firmly onthe trocar trigger 130 in the forward position, the trocar/implant arecarefully advanced into the suprachoroidal space until the implantproximal sleeve 152 just passes the scleral spur and enters thesuprachoroidal space—in some embodiments, approximately half (or about0.4 mm to about 0.7 mm) of the implant sleeve 152 remains in theanterior chamber.

In accordance with several embodiments, during implantation or insertionof the implant 120, an obturator (e.g., trocar 144) extends through theimplant or stent lumen 154 to advantageously prevent tissue ingress andlumen clogging during implant insertion (e.g., prior to removal of thetrocar 144 from the implant lumen 154). Moreover, advantageously, and inaccordance with several embodiments, a generally rounded, and not sharptrocar or obturator tip or distal end 170 is utilized to glide smoothlydown the sclera and prevent any undesirable sticking, scraping and/orattendant wound healing/fibrosis/encapsulation issues, while still beingsharp enough to dissect and separate the ciliary muscle attachment inorder to enter the suprachoroidal space atraumatically.

In accordance with some non-limiting embodiments, the outer diameter ofthe stent or implant 120 is between about 300 μm and 400 μm (e.g., 350μm, 360 μm, 375 μm, 380 μm, 390 μm), which can advantageously avoidand/or mitigate any cyclodialysis cleft issues related withimplantation. For example, in some embodiments, the delivery device 110does not create a cyclodialysis cleft substantially larger than theimplant 120 itself, and in other embodiments, does not create acyclodialysis cleft in that the delivery device 110 and implant 120 aredelivered through fibrous tissue bands of the ciliary muscle as opposedto dissecting the ciliary muscle from the sclera at the anterior chamberangle.

Next, as illustrated in FIG. 21 , the trocar trigger 130 is moved in arear or proximal direction 182 or position by the operator so that thetrocar 144 is retracted from the implant lumen 154 and thesuprachoroidal space 34. In some embodiments, once the implant or stentis in position at the proper depth, the trocar trigger button is slidbackwards until the implant or stent 120 is released. In accordance withseveral embodiments, such a backwards movement of the trocar trigger 130helps to inhibit or prevent deep placement of the stent or implant 120within the suprachoroidal space. (Similar configurations can beefficaciously employed in connection with the placement of the implant220, as needed or desired.) In some embodiments, a backing tube (e.g.,insertion sleeve 140) is configured to react against a proximal end ofthe implant 120 during removal of the trocar 144.

As illustrated in FIG. 22 , the delivery device 110 may then beretracted and the insertion sleeve 140 can be removed from the anteriorchamber 32 with the implant 120 remaining within the eye 10 and at leasta portion implanted in the suprachoroidal space 34.

In some embodiments, the operator confirms that the implant is in aproper position (e.g., the proximal end rests in the anterior chamberwith an unobstructed inlet) using the operating microscope andgonioprism. The anterior chamber can be irrigated and aspirated withbalanced salt solution (BSS) to remove all viscoelastic. If needed, theposterior edge of the incision is pressed down to facilitatesubstantially complete removal of the viscoelastic. The anterior chambercan then be inflated with saline solution to achieve physiologicpressure, as required.

In some embodiments, a predetermined curvature of both (or at least oneof) the implant 120 and delivery device 110 is provided to desirablykeep pressure on the sclera during implantation and prevent “understeer”or choroid penetration. The delivery device 110 can be curved tomaintain the implant 120 at the same curvature during the shelf life,which desirably prevents plastic creep and thus maintains the implant'sor stent's curvature specification. In one non-limiting embodiment, thecurvature is larger than a diameter of the eye (e.g., larger than the 1inch) in order to maintain the pressure on the sclera.

Delivery Device for Advancing Implant Through Device-Formed CornealIncision

FIGS. 23 and 24 show different views of an implant delivery device,inserter or applicator 210, preloaded with an ocular implant 220, inaccordance with some embodiments. The delivery device 210 is configuredto deliver and position the implant 220 in the suprachoroidal space 34of the eye 10. In some embodiments, the delivery method is performed viaan ab interno procedure. In some embodiments, the implant is deliveredthrough a self-sealing corneal incision (e.g., at or near the limbus)formed by a corneal penetration needle of the delivery device 210. Theimplant 220 may be preloaded on or within the delivery device 210 (e.g.,on an obturator, or trocar, of the delivery device 210) and provided asa kit within a single packaging. In some embodiments, the implant 220 isnot preloaded on the delivery device 210 (e.g. not preloaded prior toshipping in the packaging).

The delivery device 210 can be provided in a sterile packaging forsingle-use operation. For example, a double polythene bag may be usedfor sterility purposes, in combination with a blister packaging tofacilitate use by the operator while still maintaining safe usage.

The delivery device 210 is generally elongate in structure, andgenerally comprises an outer housing and handpiece 222, a removableprotective tube 224, a corneal penetration needle assembly 226, a trocarassembly 228, a trocar trigger 230, a pusher tube assembly 328, a pushertube trigger 330, a trigger safety device 232 and/or two pairs of reuseprevention structures 234 a, 234 b and 334 a, 334 b.

The outer housing 222 is similar to the outer housing 122 and enclosesvarious componentry of the delivery device 210 and can comprise twohousing portions such as a left housing portion 236 a and a righthousing portion 236 b, which are attached during fabrication of thedelivery device 210.

Selected portions of the outer housing 222 have ergonomic features suchas the hand grip area 238 a which has a ribbed texture or the like tofacilitate manual handling by a surgeon, medical operator orpractitioner (a similar hand grip area is provided on the right housingportion 236 b). Various internal structures of the outer housing 222engage the other components of the delivery device 210, as discussedfurther below.

The outer housing 222 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the outer housing 222 comprises a thermoplastic material,such as medical grade polycarbonate that is gamma stable.

The outer housing 222 can efficaciously dimensioned in various suitablemanners, as required or desired. In one non-limiting embodiment, theouter housing 222 has a length of about 5.60 inches, though otherlengths may also be efficaciously utilized, for example, based on thesize of the user's hand (e.g., from about 4 inches to about 8 inches andany length in between).

The protective cover tube 224 may be removably mounted on a portion ofthe corneal penetration needle assembly 226 that extends beyond a distalend of the outer housing 222. The protective cover tube 224 may beremoved before the delivery device 210 is used. One purpose of theprotective cover tube 224 may be to protect the corneal penetrationneedle assembly 226 and the components therein during packaging,shipping and travel of the implant delivery device 210.

The protective cover tube 224 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the protective cover tube 224 comprises a thermoplastic,such as low density polyethylene (LDPE).

The corneal penetration needle assembly 226 generally comprises acorneal penetration needle 240 and a support member 242 (e.g., sleeve)fixedly attached thereto and to the outer housing 222. Optionally, aseal 243 is provided to further protect the inner componentry of thedelivery device 210 from undesirable fluid entrance. Distal portions ofthe corneal penetration needle 240 and support member 242 may be exposedand extend beyond the distal tip of the delivery device 210, whileproximal portions of the corneal penetration needle 240 and supportmember 242 may be contained within the outer housing 222. Portions ofthe needle 240 may comprise a hydrophilic or hydrophobic coating. Thecorneal penetration needle assembly 226 is discussed in further detaillater herein.

The trocar assembly 228 generally comprises an obturator, or trocar 244and a trocar support member 246 (e.g., collar) fixedly attached thereto.The trocar support member 246 is mechanically coupled, connected orattached to the actuatable trocar trigger 230. A substantial distalportion of the trocar 244 extends through the corneal penetration needle240 (and pusher tube) with a distal end portion also extending throughthe implant 220. A proximal portion of the trocar 244 and the trocarsupport member 246 are contained within the outer housing 222. Thetrocar assembly 228 is discussed in further detail later herein.

The trocar trigger 230 generally comprises an upper finger or thumbactuatable portion 248 and a lower main body portion 250. The actuatabletrigger portion 248 generally extends outside the outer housing 222while the main body portion 250 is generally contained within the outerhousing 222. Before use, the trocar trigger 230 is in a rear positionand, when in use, it is utilized to first advance and then retract thetrocar 244. The trigger main body portion 250 is mechanically coupled,connected or attached to the trocar assembly 228. The trocar trigger 230is also mechanically and/or operatively coupled to the pusher tubetrigger 330. The trocar trigger 230 is discussed in further detail laterherein.

The pusher tube assembly 328 generally comprises a pusher tube 344 and apusher tube collar 346 fixedly attached thereto. The pusher tube collar346 is mechanically coupled, connected or attached to the actuablepusher tube trigger 330. A substantial portion of the distal portion ofthe pusher tube 344 extends through the insertion needle 340, with adistal end being positioned proximal of the implant 220. A proximalportion of the pusher tube 344 and the pusher tube collar 346 arecontained within the outer housing 222. The pusher tube assembly 328 isdiscussed in further detail later herein.

The pusher tube trigger 330 generally comprises an upper portion 348distally proximate to the upper finger or thumb actuable trocar triggerportion 248 and a lower main body portion 350. The upper portion 348generally extends outside the housing 222 while the main body portion350 is generally contained within the housing 222. Before use, thepusher tube trigger 330 is in a rear position and, when in use, it isutilized to advance the pusher tube 344 (and the implant 220). Thetrigger main body portion 350 is mechanically coupled, connected orattached to the pusher tube device 328. The pusher tube trigger 330 isalso mechanically and/or operatively coupled to the trocar trigger 230.The pusher tube trigger 330 is discussed in further detail later herein.

The trigger safety member 232 (e.g., clip) may be removable andpositioned generally forwardly with respect to the pusher tube trigger330. The trigger safety member 232 is mechanically coupled or engagedwith the pusher tube trigger 330. In some embodiments, the triggersafety member 232 inhibits undesirable motion of the pusher tube trigger330 and the trocar trigger 230 during packaging, shipping and travel ofthe implant delivery device 210. The trigger safety member 232 may besubstantially the same in structure as the trigger safety device 132discussed above.

The reuse prevention structures 234 a, 234 b and 334 a, 334 b may bemounted on each side of the trocar trigger 230 and the pusher tubetrigger 330 respectively, and within the outer housing 222. The reuseprevention structures 234 a, 234 b and 334 a, 334 b advantageouslyprovide a safety function to disallow reuse of the delivery device 210so as to prevent any cross-contamination between unauthorized reuse ofthe single use device 210. In some embodiments, the reuse preventionstructures 234 a, 234 b and 334 a, 334 b comprise glue blocks orpreforms that are adapted to melt or dissolve when any unapprovedre-sterilization of the delivery device 210 is attempted and lock or jamthe trocar trigger 230 and the pusher tube trigger 330 so that theirmovement is thwarted. In some embodiments, a hot melt adhesive is usedto freeze the trigger mechanism and prevent use after autoclave.

The implant 220 has an implant body 251 with a proximal sleeve 252 andis located within a distal end portion of the insertion needle 240 whenthe delivery device 210 is loaded with the implant prior to packagingand storage or before use. The implant 220 is substantially the same instructure as the implant 120 discussed above.

FIGS. 25-40 show different views of the insertion or corneal penetrationneedle assembly 226 and insertion or corneal penetration needle 240 inaccordance with some embodiments. The insertion needle 240 is agenerally elongated tubular structure with a lumen 262 extendingtherethrough and a distal curved or non-linear portion 264 to desirablyfacilitate ab interno suprachoroidal implantation. The insertion needle240 has a distal end cutting tip 265 which allows corneal penetration bythe device to desirably form a self-sealing incision in the cornea(e.g., at or adjacent the limbus). The cutting tip 265 is advantageouslysized, shaped and dimensioned to form such a self-sealing incision.

The insertion needle support 242 is an elongated member through which aportion of the needle 240 extends and is attached thereto. The insertionneedle support 242 may include a collar 266 that mates with acorresponding portion of the outer housing 222 to fixedly attach thesestructures.

A seal 243 is mounted on a proximal end portion of the insertion needle240. The seal 243 may advantageously protect the inner componentry ofthe delivery device 210 from undesirable fluid entrance and may engagean internal structure of the delivery device 210 and/or housing 222. Theinsertion or corneal penetration needle 240 may comprise a hydrophilicor hydrophobic coating along at least a portion of its length.

The insertion needle 240 receives a portion of the pusher tube 344 thatpasses through the needle lumen 262 and contains the preloaded implant220 distal of the pusher tube 344, which in turn receives a portion ofthe trocar 244. The needle distal curved or non-linear portion 264advantageously provides proper curvature and alignment of the trocar 244and the implant 220 for suprachoroidal implantation.

The insertion needle assembly 226 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the insertion sleeve 240 and support member 242 comprisestainless steel and are welded (spot or continuous) to form theassembly, and the seal 243 can comprise silicone or the like. Theinsertion or corneal penetration needle 240 can efficaciously comprise25±5 gauge hypodermic tubing, as required or desired, including, 20, 21,22, 23, 24, 25, 26, 27, 28, 29 and 30 gauge.

The insertion needle assembly 226 can efficaciously be dimensioned invarious suitable manners, as required or desired. In one non-limitingembodiment, the length L₂₅₁ is about 1.22 inches, the curved length L₂₅₂is about 0.3 inches, the diameter D₂₅ is about 0.02 inches, the radiusof curvature R₂₅ is about 1 inch, and the width W₂₆ is about 0.031inches. The radius of curvature R₂₅ can have the same or substantiallythe same radius of curvature as the trocar 244. In some embodiments, thecurvature of the insertion needle assembly 226 is adapted to be largerthan a diameter of the eye (e.g., greater than 1 inch) to, for example,maintain pressure on the sclera during a delivery or implantationprocedure.

FIGS. 31 and 32 show different views of the trocar device or assembly228, in accordance with some embodiments. The obturator, or trocar 244is a generally elongated structure with a curved or non-linear distalportion 268 with a distal-most end 270 that is configured to optimallypenetrate ocular tissue so as to access the suprachoroidal space 34.

The trocar 244 extends through the trocar support member 246, which isconfigured to engage the trocar trigger 230, and be advanceable andretractable on actuation of the trigger 230. The curved distal portion268 has a predetermined curvature to allow a proper angle of attack topenetrate ocular tissue to provide access for implantation of theimplant 220 in the suprachoroidal space 34.

More particularly, a collar portion 247 of the trocar support member 246is mechanically engaged, coupled, connected or fixedly attached to arecessed portion of the trocar trigger 230. Thus, actuation, advancementor retraction of the trocar trigger 230 results in movement, advancementand retraction of the trocar 244.

The trocar assembly 228 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar 244 comprises a metal or metal alloy such asspring tempered 304 stainless steel with a predetermined flexibility andresilience, and the trocar support member 246 comprises a metal or metalalloy such as 303 stainless steel with predetermined properties. Thetrocar 244 and trocar support member 246 (e.g., collar) can be weldedtogether (spot or continuous welding), or otherwise attached in othersuitable manners, for example molding and the like, as needed ordesired.

The trocar assembly 228 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₃₂ of the trocar distal curvedportion 268 is about 1 inch (which generally conforms to the needle's,pusher tube's and implant's radius of curvature and prevents implantcreep and disorientation), the diameter D₃₂ is about 0.006 inches (whichprovides a low tolerance fit within the implant's lumen), the curvedlength L₃₂₁ is about 0.67 inches, the length L₃₂₂ is about 2.1 inches,the overall unbent length of the trocar 244 is about 3.15 inches, theradius of curvature of the trocar distal end tip 270 is in the rangefrom about 0.001 to about 0.003 inches, and the dimension H₃₂ is about0.22 inches. In various embodiments, the radius of curvature R₃₂ of thetrocar distal curved portion 268 can range from 0.4 inches to about 2.2inches. In some embodiments, the curvature of the distal curved portion268 is adapted be slightly larger than a diameter of the eye (e.g.,larger than 1 inch) to, for example, maintain pressure on the scleraduring the delivery or implantation procedure. It should be appreciated,that the above non-limiting dimensions can involve that at least thetrocar dimensions H₃₂, R₃₂ and/or L₃₂₁ (or other related dimensions) canreflect an after “bend” manufacturing or fabrication process or stepthat has been performed or implemented on the trocar 244.

FIG. 33 shows a different view of the trocar trigger 230, in accordancewith some embodiments. The ergonomic upper finger or thumb touch portion248 has a ribbed texture configuration to facilitate its actuation bythe operator. The lower main body portion 250 has several features thatallow for the operation of the trocar trigger 230.

The trigger body portion 250 comprises a slot, cavity, opening orrecessed portion 271 which mates with and attaches to a portion of thetrocar collar portion 247 thereby effectively coupling and connectingthe trigger 230 and the trocar 244. The trigger body portion 250 mayalso comprise multiple pins 274 disposed generally symmetrically oneither side which slidably engage the internal structure of the housing222 such as the left and right slots therein, one of which slots isdepicted by reference numeral 278 b in FIG. 24 .

The trigger body portion 250 may further comprise slots 276 on each sidewhich respectively receive the reuse prevention structures 234 a and 234b that are mounted therein. The reuse prevention structures (e.g., glueblocks or preforms) may be configured to melt or otherwise dissolve ordegrade and lock the trocar trigger 230 to prevent unapproved use forthe safety of the patient. In some embodiments, a hot melt adhesive isused to freeze the trigger mechanism and prevent use after autoclave.

The trocar trigger 230 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the trocar trigger 230 comprises a plastic or thermoplastic,such as polyethylene.

FIGS. 34 and 35 show different views of the pusher tube assembly 328, inaccordance with some embodiments. The pusher tube 344 is a generallyelongated structure with a curved or non-linear distal portion 368.

The pusher tube 344 extends from the pusher tube support member 346 thatis configured to engage the pusher tube trigger 330, and be advanceableon actuation of the trigger 330, and desirably be lockable thereafter,in some embodiments. The curved distal portion 368 may have apredetermined curvature to allow a proper angle of attack for the trocar244 to penetrate ocular tissue to provide access for implantation of theimplant 220 in the suprachoroidal space 34. The predetermined curvaturemay be configured to match the curvature of the sclera.

More particularly, a collar portion 347 of the pusher tube collar 346mechanically engages, couples, connects or fixedly attaches to arecessed portion of the pusher tube trigger 330. Thus, actuation andadvancement of the pusher tube trigger 330 results in movement andadvancement of the pusher tube 344.

The pusher tube assembly 328 can efficaciously be fabricated fromvarious suitable materials, as required or desired. In one non-limitingembodiment, the pusher tube 344 comprises nitinol tubing, and the pushertube collar 346 comprises nitinol bar stock. The pusher tube 344 andcollar 346 can be welded together (spot or continuous welding), orotherwise attached in other suitable manners, for example molding andthe like, as needed or desired.

The pusher tube assembly 328 can efficaciously be dimensioned in varioussuitable manners, as required or desired. In one non-limitingembodiment, the radius of curvature R₃₅ of the pusher tube distal curvedportion 368 is about 1 inch (which generally conforms to the needle's,trocar's and implant's radius of curvature and prevents implant creepand disorientation), the diameter D₃₅ is about 0.014 inches (whichprovides a low tolerance fit within the needle's lumen), the curvedlength L₃₅₁ is about 0.5 inches, the length L₃₅₂ is about 2.1 inches,and the overall unbent length of the pusher tube 344 is about 2.57inches. In various embodiments, the radius of curvature R₃₅ of thepusher tube distal curved portion 368 can range from 0.4 inches to about2.2 inches. In some embodiments, the curvature of the pusher tube distalcurved portion 368 is adapted to be slightly larger than a diameter ofan eye (e.g., greater than 1 inch), for example, maintain pressure onthe sclera during the delivery or implantation procedure. It should beappreciated, that the above non-limiting dimensions can involve that atleast the pusher tube dimensions L₃₅₁ and/or R₃₅ (or other relateddimensions) can reflect an after “bend” manufacturing or fabricationprocess or step that has been performed or implemented on the pushertube 344.

FIG. 36 shows a different view of the pusher tube trigger 330, inaccordance with some embodiments. The upper trigger portion 348 isdistally disposed of the trocar trigger portion 248 and actuable withmovement of the same. The lower main body portion 350 has severalfeatures that allow for the operation of the pusher tube trigger 330.

The trigger main body portion 350 may comprise a slot, cavity, openingor recessed portion 371 that mates with and attaches to a portion of thepusher tube collar portion 347, thereby effectively coupling andconnecting the trigger 330 and the pusher tube 344. The trigger bodyportion 350 may also comprise multiple pins 374 disposed generallysymmetrically on either side that slidably engage the internal structureof the housing 222 such as the left and right slots therein (one ofwhich slots is depicted by reference numeral 278 b in FIG. 24 .)

The trigger main body portion 350 may further comprise slots 376 on eachside which respectively receive the reuse prevention structures 334 aand 334 b that are mounted therein. The reuse prevention structures 334a and 334 b are adapted to prevent unapproved use for the safety of thepatient.

The pusher tube trigger 330 can efficaciously be fabricated from varioussuitable materials, as required or desired. In one non-limitingembodiment, the pusher tube trigger 330 comprises a plastic orthermoplastic such as polyethylene.

FIG. 37 is a detailed view illustrating the attachment or mating betweenthe trocar assembly 228 and the trocar trigger 230 and the attachment ormating between the pusher tube device 328 and the pusher tube trigger330. In particular, the trocar device collar portion 247 engages and isreceived within the trocar trigger recessed portion 271 and the pushertube collar portion 347 engages and is received within the pusher tubetrigger recessed portion 371, thereby operatively coupling the trocar244 with its trigger 230 and the pusher tube 344 with its trigger 330.

FIGS. 38A and 38B illustrate certain non-limiting dimensions based onthe positions of the trocar trigger 230 and the pusher tube trigger 330in connection with, in some embodiments, the ocular implant 220. In FIG.38A, which also shows the implant 220 loaded, both the trocar and pushertube triggers and are in the forward position, and in a non-limitingembodiment the length L381 is about 0.002 inches. In FIG. 38B, thepusher tube trigger 330 is in a generally fully forward position, and insome embodiments locked, as needed or desired, and the trocar trigger230 is retracted, and in a non-limiting embodiment the length L₃₈₂ isabout 0.064 inches.

The delivery device 210 generally comprises, but is not limited to,materials composed of stainless steel, molded plastic and nitinol, amongothers and equivalents thereof.

Methods of Implant Delivery Through Device-Formed Corneal Incision

FIGS. 39-44 illustrate steps or acts of a surgical procedure or methodof implanting the ocular implant 220 in the suprachoroidal space 34 ofthe eye 10 using the implant delivery or inserter system or device 210in accordance with some embodiments. Given the details in the figuresthe surgical method should be self-explanatory, however some textualdescription is provided below. (Briefly, and in accordance with someembodiments: in FIG. 39 both the triggers 230 and 330 are in a rearposition; in FIG. 40 both the triggers 230 and 330 are in a forwardposition; in FIG. 41 both the triggers 230 and 330 are still ormaintained in a generally forward position; in FIG. 42 both the triggers230 and 330 are still or maintained in a generally forward position; inFIG. 43 the trocar trigger 230 is retracted and/or in a rear positionwhile the pusher tube trigger 330 is in a locked position; and in FIG.44 the trocar trigger 230 remains in its rear position.)

In some embodiments, a surgical microscope and the patient arepositioned to provide a substantially clear visualization of thetrabecular meshwork through a gonioprism on the nasal side of the eye.The patient's head can be tilted as far as practical from the surgeon,and the microscope can be tilted toward the surgeon to ensure a properviewing angle.

The delivery device 210 is removed from its package. The protectivecover tube 224 is carefully removed from the insertion needle and thesafety member 232 holding the triggers is removed by the operator takingcare that the triggers 230 and 330 are maintained in the rear position.

If a gonioprism is used, the gonioprism is placed on the cornea, and theanterior chamber angle is inspected using the gonioprism to ensure agood visualization at the nasal implant location. The gonioprism is thenremoved. Other visualization devices may be used or the procedure may beperformed without use of a visualization device.

FIG. 39 illustrates formation of a self-sealing incision 370 by theinsertion or corneal penetration needle 240, and more particularly, thecutting distal end tip 265 of the needle 240 of the delivery device 210,such that a portion of the needle 240 extends into the anterior chamber32. At this stage, both the trocar trigger 230 and the pusher tubetrigger 330 are maintained in the rear position by the operator. In someembodiments, a temporal clear corneal incision is made using a sharpcutting tip of the device. If a clear corneal incision has already beenmade, a cohesive viscoelastic may be used to maintain the anteriorchamber before passing the needle 240 through the incision.

FIG. 40 illustrates forward deployment of the triggers such that theimplant 220 is exposed and advanced within the anterior chamber 32 alongwith the trocar 244 such that the trocar distal end tip 270 extends by apredetermined distance beyond the implant 220. In some embodiments, oncethe insertion needle enters the eye and is past the pupillary margin,the trocar trigger (and as such the pusher tube trigger 330) areadvanced to the fully forward position, thereby exposing the implant orstent 220 and the trocar tip 270.)

As illustrated in FIG. 41 , the implant 220 is advanced across theanterior chamber 32 and positioned at the implantation site with thetrocar distal end 270 adjacent the fibrous attachment zone 60. At thisstage, both triggers are maintained in the forward position by theoperator, with the pusher tube trigger 330 desirably locked in positionso that the implant 220 cannot be proximally displaced. The angle ofattack θ₄₁ is about 15° (degrees), though 10, 11, 12, 13, 14, 15, 16,17, 18, 19 and 20° (degrees) or other attack angles may efficaciously beutilized, as needed or desired. In some embodiments, a gonioprism isplaced on the cornea, and the trocar/implant are guided across theanterior chamber to the nasal angle. Care is taken to avoid contact withthe lens, cornea and iris. The trocar/implant may be advanced to theanterior chamber angle just posterior to the scleral spur. In someembodiments, the delivery device 210 has a built-in configuration ordesign for a generally downward angle of about 15° (±5°-10°) (degrees)at a site of implantation or towards the site of implantation.

Next, as illustrated in FIG. 42 , the trocar distal tip or end 270penetrates through the tissue of and/or adjacent the fibrous attachmentzone 60 and the implant 220 is advanced until its implantation positionhas been reached in the suprachoroidal space 34 with a predeterminedportion of the implant sleeve 252 extending into the anterior chamber32. The trocar trigger 230 is maintained in the forward position by theoperator at this stage. In some embodiments, a generally narrow passageis created into the suprachoroidal space by gently separating the irisprocesses away from the scleral spur with the tip of the insertiontrocar until the anterior and posterior portions of the scleral spur aresubstantially fully visible on a limited area—e.g., create anapproximately 0.5 mm to a maximum of about 1 mm width opening. Thetrocar/implant are continued to be advanced along the posterior marginof the scleral spur. With finger or thumb holding the rear/trocartrigger in the forward position, the trocar/implant are carefullyadvanced into the suprachoroidal space until the implant proximal sleevejust passes the scleral spur and enters the suprachoroidal space—in someembodiments, approximately half (or about 0.4 mm to about 0.7 mm) of theimplant sleeve remains in the anterior chamber.

In accordance with several embodiments, during implantation or insertionof the implant 220 the trocar, or obturator, 244 extends through theimplant or stent lumen 154 to advantageously prevent tissue ingress andlumen clogging during implant insertion (prior to removal of the trocar,or obturator, 244 from the implant lumen 154).

Next, as illustrated in FIG. 43 , the trocar trigger 230 is moved in arear or proximal direction 282 by the operator so that the trocar 244 isretracted from the implant lumen and the suprachoroidal space 34. Insome embodiments, once the implant or stent 220 is in position at theproper depth, the trocar trigger button is slid backwards until theimplant or stent 220 is released. The backwards movement of the trocartrigger 230 may advantageously prevent or inhibit over-insertion of theimplant 220. In some embodiments, a backing tube is configured to reactagainst a proximal end of the implant 220 during removal of the trocar244.

As illustrated in FIG. 44 , the delivery device 210 is retracted and theinsertion needle 240 is removed from the anterior chamber 32 with theimplant 220 remaining within the eye 10 and implanted in thesuprachoroidal space 34. In some embodiments, the incision 270 desirablyself-seals to facilitate quick recovery without requiring sutures.

In some embodiments, the operator confirms that the implant is in aproper position (e.g., the proximal end rests in the anterior chamberwith an unobstructed inlet) using the operating microscope andgonioprism. The anterior chamber can be irrigated and aspirated withbalanced salt solution (BSS) to remove all viscoelastic, if used. Ifneeded, the posterior edge of the incision is pressed down to facilitatesubstantially complete removal of the viscoelastic, if used. Theanterior chamber can then be inflated with saline solution to achievephysiologic pressure, as required.

In some embodiments, a predetermined curvature of both (or at least oneof) the implant or stent 220 and delivery device 210 is provided todesirably keep pressure on the sclera during implantation and prevent“understeer” or choroid penetration. The delivery device 210 can becurved to maintain the implant or stent 220 at the same curvature duringthe shelf life which desirably prevents plastic creep and thus maintainthe implant's or stent's curvature specification. In one non-limitingembodiment, the curvature is larger than a diameter of the eye (e.g.,larger than a 1 inch diameter) in order to maintain the pressure on thesclera.

In some embodiments, the pusher tube 344 is configured to react againsta proximal end of the implant or stent 220 during trocar or obturatorremoval. Advantageously, the “lazy” curve or curvature of the needle 240and/or substantially the entire system 210 (see, e.g., FIGS. 39 to 44 )maintains, in accordance with some embodiments, about a 15° angle at theimplantation site, though 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 and 20°(degrees) or other angles may efficaciously be utilized, as needed ordesired.

Moreover, in accordance with some embodiments, the needle 240advantageously traverses across the eye (finite height anterior chamberclearance) without contacting the iris or cornea. In some embodiments,the implant or stent 220 is maintained at its specified, predeterminedor required or desired curvature throughout substantially its shelflife, for example, to prevent plastic creep.

Drugs and Therapeutic Agents

In some embodiments, the implants disclosed herein can provide fordelivery of a therapeutic agent or drug. The therapeutic agent can be,for example, an intraocular pressure-lowering drug. In some embodiments,the therapeutic agent or drug is introduced concurrently with thedelivery of the shunt to the eye. The therapeutic agent or drug can bepart of the implant itself. For example, the therapeutic agent or drugcan be embedded in the material of the shunt, or coat at least a portionof the implant. The therapeutic agent or drug may be present on variousportions of the implant. For example, the therapeutic agent or drug maybe present on the distal end of the implant, or the proximal end of theimplant. The implant can include combination of therapeutic agents ordrugs. The different therapeutic agents or drugs can be separated orcombined. One kind of therapeutic agent or drug can be present at theproximal end of the implant, and a different kind of therapeutic agentor drug can be present at the distal end of the implant. For example, ananti-proliferative agent may be present at the distal end of the implantto prevent growth, and a growth-promoting agent may be applied to theproximal end of the implant to promote growth.

Examples of drugs may include various anti-secretory agents;antimitotics and other anti-proliferative agents, including amongothers, anti-angiogenesis agents such as angiostatin, anecortaveacetate, thrombospondin, VEGF receptor tyrosine kinase inhibitors andanti-vascular endothelial growth factor (anti-VEGF) drugs such asranibizumab (LUCENTIS®) and bevacizumab (AVASTIN®), pegaptanib(MACUGEN®), sunitinib and sorafenib and any of a variety of knownsmall-molecule and transcription inhibitors having anti-angiogenesiseffect (additional non-limiting examples of such anti-VEGF compounds aredescribed in Appendix A, which is attached herewith and made a part ofthis application); classes of known ophthalmic drugs, including:glaucoma agents, such as adrenergic antagonists, including for example,beta-blocker agents such as atenolol, propranolol, metipranolol,betaxolol, carteolol, levobetaxolol, levobunolol and timolol; adrenergicagonists or sympathomimetic agents such as epinephrine, dipivefrin,clonidine, aparclonidine, and brimonidine; parasympathomimetics orcholingeric agonists such as pilocarpine, carbachol, phospholine iodine,and physostigmine, salicylate, acetylcholine chloride, eserine,diisopropyl fluorophosphate, demecarium bromide); muscarinics; carbonicanhydrase inhibitor agents, including topical and/or systemic agents,for example acetozolamide, brinzolamide, dorzolamide and methazolamide,ethoxzolamide, diamox, and dichlorphenamide; mydriatic-cycloplegicagents such as atropine, cyclopentolate, succinylcholine, homatropine,phenylephrine, scopolamine and tropicamide; prostaglandins such asprostaglandin F2 alpha, antiprostaglandins, prostaglandin precursors, orprostaglandin analog agents such as bimatoprost, latanoprost, travoprostand unoprostone.

Other examples of drugs may also include anti-inflammatory agentsincluding for example glucocorticoids and corticosteroids such asbetamethasone, cortisone, dexamethasone, dexamethasone 21-phosphate,methylprednisolone, prednisolone 21-phosphate, prednisolone acetate,prednisolone, fluorometholone, loteprednol, medrysone, fluocinoloneacetonide, triamcinolone acetonide, triamcinolone, beclomethasone,budesonide, flunisolide, fluticasone, hydrocortisone, hydrocortisoneacetate, loteprednol, rimexolone and non-steroidal anti-inflammatoryagents including, for example, diclofenac, flurbiprofen, ibuprofen,bromfenac, nepafenac, and ketorolac, salicylate, indomethacin,ibuprofen, naxopren, piroxicam and nabumetone; anti-infective orantimicrobial agents such as antibiotics including, for example,tetracycline, chlortetracycline, bacitracin, neomycin, polymyxin,gramicidin, cephalexin, oxytetracycline, chloramphenicol, rifampicin,ciprofloxacin, tobramycin, gentamycin, erythromycin, penicillin,sulfonamides, sulfadiazine, sulfacetamide, sulfamethizole,sulfisoxazole, nitrofurazone, sodium propionate, aminoglycosides such asgentamicin and tobramycin; fluoroquinolones such as ciprofloxacin,gatifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin;bacitracin, erythromycin, fusidic acid, neomycin, polymyxin B,gramicidin, trimethoprim and sulfacetamide; antifungals such asamphotericin B and miconazole; antivirals such as idoxuridinetrifluorothymidine, acyclovir, gancyclovir, interferon; antimicotics;immune-modulating agents such as antiallergenics, including, forexample, sodium chromoglycate, antazoline, methapyriline,chlorpheniramine, cetrizine, pyrilamine, prophenpyridamine;anti-histamine agents such as azelastine, emedastine and levocabastine;immunological drugs (such as vaccines and immune stimulants); MAST cellstabilizer agents such as cromolyn sodium, ketotifen, lodoxamide,nedocrimil, olopatadine and pemirolastciliary body ablative agents, suchas gentimicin and cidofovir; and other ophthalmic agents such asverteporfin, proparacaine, tetracaine, cyclosporine and pilocarpine;inhibitors of cell-surface glycoprotein receptors; decongestants such asphenylephrine, naphazoline, tetrahydrazoline; lipids or hypotensivelipids; dopaminergic agonists and/or antagonists such as quinpirole,fenoldopam, and ibopamine; vasospasm inhibitors; vasodilators;antihypertensive agents; angiotensin converting enzyme (ACE) inhibitors;angiotensin-1 receptor antagonists such as olmesartan; microtubuleinhibitors; molecular motor (dynein and/or kinesin) inhibitors; actincytoskeleton regulatory agents such as cyctchalasin, latrunculin,swinholide A, ethacrynic acid, H-7, and Rho-kinase (ROCK) inhibitors;remodeling inhibitors; modulators of the extracellular matrix such astert-butylhydro-quinolone and AL-3037A; adenosine receptor agonistsand/or antagonists such as N-6-cylclophexyladenosine and(R)-phenylisopropyladenosine; serotonin agonists; hormonal agents suchas estrogens, estradiol, progestational hormones, progesterone, insulin,calcitonin, parathyroid hormone, peptide and vasopressin hypothalamusreleasing factor; growth factor antagonists or growth factors,including, for example, epidermal growth factor, fibroblast growthfactor, platelet derived growth factor or antagonists thereof,transforming growth factor beta, somatotrapin, fibronectin, connectivetissue growth factor, bone morphogenic proteins (BMPs); cytokines suchas interleukins, CD44, cochlin, and serum amyloids, such as serumamyloid A.

Other therapeutic agents may include neuroprotective agents such aslubezole, nimodipine and related compounds, and including blood flowenhancers such as dorzolamide or betaxolol; compounds that promote bloodoxygenation such as erythropoeitin; sodium channels blockers; calciumchannel blockers such as nilvadipine or lomerizine; glutamate inhibitorssuch as memantine nitromemantine, riluzole, dextromethorphan oragmatine; acetylcholinsterase inhibitors such as galantamine;hydroxylamines or derivatives thereof, such as the water solublehydroxylamine derivative OT-440; synaptic modulators such as hydrogensulfide compounds containing flavonoid glycosides and/or terpenoids,such as Ginkgo biloba; neurotrophic factors such as glial cell-linederived neutrophic factor, brain derived neurotrophic factor; cytokinesof the IL-6 family of proteins such as ciliary neurotrophic factor orleukemia inhibitory factor; compounds or factors that affect nitricoxide levels, such as nitric oxide, nitroglycerin, or nitric oxidesynthase inhibitors; cannabinoid receptor agonists such as WIN55-212-2;free radical scavengers such as methoxypolyethylene glycol thioester(MPDTE) or methoxypolyethlene glycol thiol coupled with EDTA methyltriester (MPSEDE); anti-oxidants such as astaxathin, dithiolethione,vitamin E, or metallocorroles (e.g., iron, manganese or galliumcorroles); compounds or factors involved in oxygen homeostasis such asneuroglobin or cytoglobin; inhibitors or factors that impactmitochondrial division or fission, such as Mdivi-1 (a selectiveinhibitor of dynamin related protein 1 (Drp1)); kinase inhibitors ormodulators such as the Rho-kinase inhibitor H-1152 or the tyrosinekinase inhibitor AG1478; compounds or factors that affect integrinfunction, such as the Beta 1-integrin activating antibody HUTS-21;N-acyl-ethanaolamines and their precursors, N-acyl-ethanolaminephospholipids; stimulators of glucagon-like peptide 1 receptors (e.g.,glucagon-like peptide 1); polyphenol containing compounds such asresveratrol; chelating compounds; apoptosis-related protease inhibitors;compounds that reduce new protein synthesis; radiotherapeutic agents;photodynamic therapy agents; gene therapy agents; genetic modulators;auto-immune modulators that prevent damage to nerves or portions ofnerves (e.g., demyelination) such as glatimir; myelin inhibitors such asanti-NgR Blocking Protein, NgR(310)ecto-Fc; other immune modulators suchas FK506 binding proteins (e.g., FKBP51); and dry eye medications suchas cyclosporine A, delmulcents, and sodium hyaluronate.

Other therapeutic agents that may be used include: other beta-blockeragents such as acebutolol, atenolol, bisoprolol, carvedilol, asmolol,labetalol, nadolol, penbutolol, and pindolol; other corticosteroidal andnon-steroidal anti-inflammatory agents such aspirin, betamethasone,cortisone, diflunisal, etodolac, fenoprofen, fludrocortisone,flurbiprofen, hydrocortisone, ibuprofen, indomethacine, ketoprofen,meclofenamate, mefenamic acid, meloxicam, methylprednisolone,nabumetone, naproxen, oxaprozin, prednisolone, prioxicam, salsalate,sulindac and tolmetin; COX-2 inhibitors like celecoxib, rofecoxib andValdecoxib; other immune-modulating agents such as aldesleukin,adalimumab (HUMIRA®), azathioprine, basiliximab, daclizumab, etanercept(ENBREL®), hydroxychloroquine, infliximab (REMICADE®), leflunomide,methotrexate, mycophenolate mofetil, and sulfasalazine; otheranti-histamine agents such as loratadine, desloratadine, cetirizine,diphenhydramine, chlorpheniramine, dexchlorpheniramine, clemastine,cyproheptadine, fexofenadine, hydroxyzine and promethazine; otheranti-infective agents such as aminoglycosides such as amikacin andstreptomycin; anti-fungal agents such as amphotericin B, caspofungin,clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole,terbinafine and nystatin; anti-malarial agents such as chloroquine,atovaquone, mefloquine, primaquine, quinidine and quinine;anti-mycobacterium agents such as ethambutol, isoniazid, pyrazinamide,rifampin and rifabutin; anti-parasitic agents such as albendazole,mebendazole, thiobendazole, metronidazole, pyrantel, atovaquone,iodoquinaol, ivermectin, paromycin, praziquantel, and trimatrexate;other anti-viral agents, including anti-CMV or anti-herpetic agents suchas acyclovir, cidofovir, famciclovir, gangciclovir, valacyclovir,valganciclovir, vidarabine, trifluridine and foscarnet; proteaseinhibitors such as ritonavir, saquinavir, lopinavir, indinavir,atazanavir, amprenavir and nelfinavir;nucleotide/nucleoside/non-nucleoside reverse transcriptase inhibitorssuch as abacavir, ddI, 3TC, d4T, ddC, tenofovir and emtricitabine,delavirdine, efavirenz and nevirapine; other anti-viral agents such asinterferons, ribavirin and trifluridiene; other anti-bacterial agents,including cabapenems like ertapenem, imipenem and meropenem;cephalosporins such as cefadroxil, cefazolin, cefdinir, cefditoren,cephalexin, cefaclor, cefepime, cefoperazone, cefotaxime, cefotetan,cefoxitin, cefpodoxime, cefprozil, ceftaxidime, ceftibuten, ceftizoxime,ceftriaxone, cefuroxime and loracarbef; other macrolides and ketolidessuch as azithromycin, clarithromycin, dirithromycin and telithromycin;penicillins (with and without clavulanate) including amoxicillin,ampicillin, pivampicillin, dicloxacillin, nafcillin, oxacillin,piperacillin, and ticarcillin; tetracyclines such as doxycycline,minocycline and tetracycline; other anti-bacterials such as aztreonam,chloramphenicol, clindamycin, linezolid, nitrofurantoin and vancomycin;alpha blocker agents such as doxazosin, prazosin and terazosin;calcium-channel blockers such as amlodipine, bepridil, diltiazem,felodipine, isradipine, nicardipine, nifedipine, nisoldipine andverapamil; other anti-hypertensive agents such as clonidine, diazoxide,fenoldopan, hydralazine, minoxidil, nitroprus side, phenoxybenzamine,epoprostenol, tolazoline, treprostinil and nitrate-based agents;anti-coagulant agents, including heparins and heparinoids such asheparin, dalteparin, enoxaparin, tinzaparin and fondaparinux; otheranti-coagulant agents such as hirudin, aprotinin, argatroban,bivalirudin, desirudin, lepirudin, warfarin and ximelagatran;anti-platelet agents such as abciximab, clopidogrel, dipyridamole,optifibatide, ticlopidine and tirofiban; prostaglandin PDE-5 inhibitorsand other prostaglandin agents such as alprostadil, carboprost,sildenafil, tadalafil and vardenafil; thrombin inhibitors;antithrombogenic agents; anti-platelet aggregating agents; thrombolyticagents and/or fibrinolytic agents such as alteplase, anistreplase,reteplase, streptokinase, tenecteplase and urokinase; anti-proliferativeagents such as sirolimus, tacrolimus, everolimus, zotarolimus,paclitaxel and mycophenolic acid; hormonal-related agents includinglevothyroxine, fluoxymestrone, methyltestosterone, nandrolone,oxandrolone, testosterone, estradiol, estrone, estropipate, clomiphene,gonadotropins, hydroxyprogesterone, levonorgestrel, medroxyprogesterone,megestrol, mifepristone, norethindrone, oxytocin, progesterone,raloxifene and tamoxifen; anti-neoplastic agents, including alkylatingagents such as carmustine lomustine, melphalan, cisplatin,fluorouracil3, and procarbazine antibiotic-like agents such asbleomycin, daunorubicin, doxorubicin, idarubicin, mitomycin andplicamycin; anti proliferative agents (such as 1,3-cis retinoic acid,5-fluorouracil, taxol, rapamycin, mitomycin C and cisplatin);antimetabolite agents such as cytarabine, fludarabine, hydroxyurea,mercaptopurine and 5-fluorouracil (5-FU); immune modulating agents suchas aldesleukin, imatinib, rituximab and tositumomab; mitotic inhibitorsdocetaxel, etoposide, vinblastine and vincristine; radioactive agentssuch as strontium-89; and other anti-neoplastic agents such asirinotecan, topotecan and mitotane.

In some embodiments, the therapeutic agent is delivered through theimplant to the desired location in the eye, such as the suprachoroidalspace of the uveoscleral outflow pathway. In some embodiments, thetherapeutic agent is delivered to the suprachoroidal space of theuveoscleral outflow pathway in combination with a therapeutic agentdelivered via trans pars plana vitrectomy, thereby delivering atherapeutic agent to both sides of the retina. In some embodiments, theimplant can improve access of topical medication to the posterior uvea.In some embodiments, the implant is used to deliver a topical medicationto treat a chorio-retinal disease.

In some embodiments, the delivery device 110 provides implantationthrough a preformed or prior corneal incision while the delivery device210 does so through a self-created and self-sealing incision such that a“closed chamber” operation is performed.

The delivery device 110 is configured, in some embodiments, so that theimplant is supported on a trocar wire or obturator in an exposedconfiguration. In some embodiments, the delivery device 210 supports theimplant on a trocar wire or obturator within an insertion or cornealpenetration needle.

In some embodiments, the delivery device 110 comprises a siliconeretainer to hold the implant in place during travel. The delivery device210, in some embodiments, incorporates a curved delivery system thatprovides adequate side loads and friction to hold the implant in placeduring travel and shipping.

The delivery device 110, in certain embodiments, employs a singletrigger operation to release the implant. The delivery device 210, inaccordance with some embodiments, utilizes a dual trigger operation toexpose and release the implant—trocar and implant pusher tube triggers.Once the insertion needle penetrates the cornea, both triggers advanceto expose the implant or stent and the trocar and obturator. The frontpusher tube trigger locks the pusher tube in a forward position, therebypreventing the implant or stent from retracting back into the needle.After implant or stent implantation, the rear trocar trigger isretracted to retract the trocar and release the implant or stent.

It should be appreciated, in accordance with some embodiments, that thedisclosed implant is prevented from backward movement basedadvantageously on the delivery device configuration. For example, theimplant 120 is prevented from backward movement because of the insertionsleeve's distal end relative dimensioning and the implant 220 isprevented from backward movement because of pusher tube's distal endrelative dimensioning.

Moreover, because of the material properties of the disclosed trocars,creep during shelf life should advantageously not be an issue ofconcern. Also, in accordance with some embodiments, given that theimplants and trocars are asymmetrically curved, this orientation aspackaged, prevents any undesirable rotation of the implants with respectto the trocars even when in use. Furthermore, in accordance with someembodiments, at least the implants and trocars have predeterminedcurvatures which, because of their selected flexibility, can conform tothe particular space or ocular location they are inserted or advancedinto.

In some embodiments, the delivery device 110 is configured for use incombination with another ocular surgery, such as cataract surgery. Thedelivery device 110 can include a preloaded implant 120 and have apre-curved tip. The device 110 advantageously may have an ergonomichandpiece.

In some embodiments, the delivery device 210 is configured forstand-alone, in-office surgery without being performed in conjunctionwith other ocular surgery (e.g., cataract surgery). The delivery device210 can include a preloaded implant 220 and can have a pre-curved tip.Also, in some embodiments, the device 210 has integrated cornealpenetration and closed chamber capability so as to perform the procedurethrough a self-sealing incision. The device 210 may advantageouslyinclude an ergonomic handpiece. Preloading the implant 220 on thedelivery instrument 210 may reduce loading errors and contribute to easeof use.

Certain embodiments provide for the implant, trocar and/or the pushertube to flex and allow for the implant to conform to the anatomy of thesuprachoroidal space.

The delivery device geometries, such as with respect to the attack angleand curvature, can advantageously ensure proper placement of the implantin the suprachoroidal space, supraciliary space, or other anatomicalspace.

In some embodiments, the low friction (e.g., polyethylene onpolycarbonate) trigger operation, in accordance with some embodiments,advantageously allows for smooth operation during the deliveryprocedures. The safety members (e.g., safety clips) may advantageouslyprevent undesirable trigger motion during shipment and transportation ofthe delivery devices.

Embodiments of the trocar or obturator material and tip shape provideseveral advantages which include: use of high temper stainless springsteel; pointed enough tip to pierce ciliary muscle attachment; roundedenough tip to prevent irritation/tissue damage in suprachoroidal spaceat sclera/choroid; material and shape allows constant force againstsclera during advancement in order to assure proper placement of implantwithin suprachoroidal space; and trocar curvature generally matchesimplant or stent shape to prevent plastic creep during shelf life.Moreover, advantageously, and in accordance with some embodiments, agenerally rounded, and not sharp trocar or obturator tip or distal end,e.g. 170 or 270, is utilized to glide smoothly down the sclera andprevent any undesirable sticking, scraping and attendant woundhealing/fibrosis/encapsulation issues, while still being sharp enough todissect and separate the ciliary muscle attachment in order to enter thesuprachoroidal space atraumatically.

Also, in accordance with some non-limiting embodiments, the outerdiameter of the stent or implant 220 is between about 300 μm and 400 μm(e.g., 350 μm, 360 μm, 375 μm, 380 μm, 390 μm), which can advantageouslyavoid and/or mitigate any cyclodialysis cleft issues related withimplantation. For example, in some embodiments, the delivery device 210does not create a cyclodialysis cleft substantially larger than theimplant 220 itself, and in other embodiments, does not create acyclodialysis cleft in that the delivery device 210 and implant 220 aredelivered through fibrous tissue bands of the ciliary muscle as opposedto dissecting the ciliary muscle from the sclera at the anterior chamberangle.

With respect to embodiments of the delivery device 210, the curved,flared and coated stainless steel insertion or corneal penetrationneedle is advantageously shaped to fit anatomically within eye the andavoid iris touch. Also, the tight corneal incision can minimize fluidloss from the eye by forming a substantially closed chamber self-sealingentry. Moreover, the lowered sliding friction of the needle shaft oncein the eye may advantageously prevent movement during this delicatesurgery, and any resultant loss of view during any interoperativegonioscopy.

In some embodiments, and once again with respect to embodiments of thedelivery device 210, the superelastic nitinol pusher tube providesbackup support for the implant or stent during implantation, and allowsminimal sliding force during trigger operation. Also, in accordance withsome embodiments, the polyethylene protective tube prevents damage tothe needle tip during shipment.

The delivery device 210, in accordance with some embodiments, canadvantageously be used in a “closed chamber” procedure, which may haveone or more of the following advantages: no viscoelastic is required toinflate the anterior chamber; there is minimal loss of fluid fromanterior chamber (this reduces chance of hypotony); no separate blade isrequired to form the corneal incision; results in faster surgery; thereis only one time entry into the eye; a safer procedure with less chanceor lowered probability for adverse event (e.g., endophthalmitis); andless expensive and more cost effective.

The curved insertion needle, trocar or obturator, and pusher tube of thedelivery device 210 also, in certain embodiments allows for retention ofthe implant or stent shape during its entire shelf life (includingduring shipping) to prevent creep (such as, loss of implant or stentcurvature). Moreover, the closed-chamber procedure can allow forenhanced surgical safety in a non-deepened anterior chamber bysubstantially matching the curvature of the cornea and allowingtraversing of the eye in an ab interno procedure.

Terminology

Conditional language, for example, among others, “can,” “could,”“might,” or “may,” unless specifically stated otherwise, or otherwiseunderstood within the context as used, is generally intended to conveythat certain embodiments include, while other embodiments do notinclude, certain features, elements and/or steps.

Methods

The methods which are described and illustrated herein are not limitedto the sequence of acts described, nor are they necessarily limited tothe practice of all of the acts set forth. Other sequences of acts, orless than all of the acts, or simultaneous occurrence of the acts, maybe utilized in practicing embodiments of the invention(s). The methodsdisclosed herein include certain actions taken by a practitioner;however, they can also include any third-party instruction of thoseactions, either expressly or by implication. For example, actions suchas “forming an incision” include “instructing the formation of anincision.”

Ranges

The ranges disclosed herein encompass any and all overlap, sub-ranges,and combinations thereof, as well as individual numerical values withinthat range. For example, description of a range such as from about 5 toabout 30 degrees should be considered to have specifically disclosedsubranges such as from 5 to 10 degrees, from 10 to 20 degrees, from 5 to25 degrees, from 15 to 30 degrees etc., as well as individual numberswithin that range, for example, 5, 10, 15, 20, 25, 12, 15.5 and anywhole and partial increments therebetween. Language such as “up to,” “atleast,” “greater than,” “less than,” “between,” and the like includesthe number recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers. For example, “about 10%”includes “10%.” For example, the terms “approximately”, “about”, and“substantially” as used herein represent an amount close to the statedamount that still performs a desired function or achieves a desiredresult.

CONCLUSION

From the foregoing description, it will be appreciated that a novelapproach for intraocular pressure control has been disclosed. While thecomponents, techniques and aspects of embodiments of the invention havebeen described with a certain degree of particularity, it is manifestthat many changes may be made in the specific designs, constructions andmethodology herein above described without departing from the spirit andscope of this disclosure.

While a number of preferred embodiments of the invention and variationsthereof have been described in detail, other modifications and methodsof using and medical, diagnostic, research and therapeutic applicationsfor the same will be apparent to those of skill in the art. Accordingly,it should be understood that various applications, modifications, andsubstitutions may be made of equivalents without departing from thespirit of embodiments of the invention or the scope of the claims.

Various modifications and applications of the embodiments of theinvention may occur to those who are skilled in the art, withoutdeparting from the true spirit or scope of the embodiments of theinvention. It should be understood that the invention(s) is not limitedto the embodiments set forth herein for purposes of exemplification, butis to be defined only by a fair reading of the appended claims,including the full range of equivalency to which each element thereof isentitled.

1-20. (canceled)
 21. An ocular implant delivery system comprising: agenerally elongated ergonomic outer housing; an elongated insertionsleeve partially disposed in the outer housing and having a lumen and anon-linear exposed distal portion extending out of a distal end of theouter housing; an implant pusher tube partially disposed in andextending outwardly from the distal end of the outer housing, passingthrough at least a portion of the lumen of the insertion sleeve; animplant supported within the distal portion of the insertion sleeve andin line with a distal end of the implant pusher tube; and a triggermechanically coupled to the outer housing such that actuation of thetrigger deploys the implant into an implantation location within an eye.22. The delivery system of claim 21, wherein the distal portion of theinsertion sleeve has a first radius of curvature that provides properalignment of the implant for suprachoroidal implantation of the implant.23. The delivery system of claim 21, wherein the distal portion of theinsertion sleeve has a radius of curvature that is between 0.4 inchesand 2.2 inches.
 24. The delivery system of claim 21, wherein the implantis made of a flexible material.
 25. The delivery system of claim 21,wherein the implant is curved to have proper curvature and alignment forsuprachoroidal implantation.
 26. The delivery system of claim 21,wherein the nonlinear exposed distal portion of the insertion sleeve anda nonlinear distal portion of the implant have matching curvatures. 27.The delivery system of claim 21, wherein the implant further comprises atherapeutic agent or drug.
 28. The delivery system of claim 27, whereinthe therapeutic agent comprises an anti-angiogenesis agent.
 29. Thedelivery system of claim 21, wherein the outer housing further comprisesreuse prevention structures designed to limit use of the delivery systemto a single use.
 30. The delivery system of claim 21, wherein theinsertion sleeve further comprises a visual aid for indicating asuitable depth of implant placement during implantation.
 31. Thedelivery system of claim 21, wherein the delivery system is provided ina sterile packaging for single-use operation.
 32. The delivery system ofclaim 21, wherein the implant is prevented from backwards movement bycontact between a proximal end of the implant and the distal end of theimplant pusher tube.
 33. The delivery system of claim 21, furthercomprising a trigger safety device mechanically engaged with the triggersuch that actuation of the trigger cannot occur while the trigger safetydevice is engaged.
 34. A method of implanting an ocular implant withinan eye, the method comprising: inserting a distal end of a deliverydevice loaded with an implant within an insertion sleeve of the deliverydevice through a pre-formed corneal incision into an anterior chamber ofan eye; advancing a distal end of the delivery device across theanterior chamber to an anterior chamber angle adjacent an implantationsite; advancing the distal end of the delivery device into theimplantation site; actuating a trigger such that the implant reactsagainst a distal end of an implant pusher tube of the delivery device asthe trigger is actuated, thus deploying the implant into theimplantation site; and removing the delivery device from the eye. 35.The method of claim 34, wherein the implantation site is in asuprachoroidal space formed between a choroid and a sclera.
 36. Themethod of claim 34, wherein the implantation site is in a supraciliaryspace formed between a ciliary body and a choroid.
 37. The method ofclaim 34, wherein the implantation site is in a fibrous attachment zoneadjacent a scleral spur.
 38. The method of claim 34, further comprisingremoving a trigger safety device before actuating the trigger.
 39. Themethod of claim 34, further comprising separating iris processes awayfrom a scleral spur with the distal end of the delivery device until theimplantation site is formed.